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FDA News Briefs for Wednesday, May 1, 2019

May 1, 2019

These Food and Drug Administration (FDA) developments came in this week:


FDA Approves First Therapy for Hepatitis C in Pediatric Patients

The FDA has granted expanded approval for Mavyret (glecaprevir and pibrentasvir; AbbVie Inc.). Mavyret is now indicated for the treatment of all 6 hepatitis C genotypes in patients aged 12 to 17 years. Mavyret was previously approved for the treatment of adults with chronic hepatitis C genotypes 1 through 6. More Information


FDA Expands Indication for Praluent

The FDA has granted expanded approval for Praluent (alirocumab; Sanofi and Regeneron Pharmaceuticals Inc.) to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. Praluent was previously approved as an adjunct to diet for the treatment of primary hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C). More Information.  


New Boxed Warning for Certain Prescription Insomnia Medications

The FDA issued a safety alert warning healthcare professionals and patients about the rare but serious injuries and deaths resulting from complex sleep behaviors (e.g., sleepwalking, sleep driving) after taking certain prescription insomnia medicines. The FDA is mandating a boxed warning for the following labels: eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist). More Information.


FDA Orders Safety Labeling Changes for Rubidium 82 Generators

The FDA issued safety changes on the labels of rubidium 82 generators to address the risk of excess radiation exposure to patients due to users administering an incorrect solution (e.g., lactated ringers) to elute the generator. Rubidium 82 is a radionuclide used to assess myocardial perfusion during positron emission tomography (PET) imaging scans. More Information.